Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Biological Ageing and Metabolic Health in Perimenopause and Menopause.
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Time-Restricted Low-Glycaemic Index Diet.
- Кому может быть актуально
- Состояния в реестре: Late-perimenopause, Menopause, Perimenopause. Базовые параметры: 45 лет — 75 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Хорватия, Cyprus
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Effect of Time-Restricted Eating in Combination With a Low Glycaemic Index Diet on Cognitive Function, Markers of Biological Age and Metabolic Health in Late-Perimenopausal and Menopausal Women: a Randomized Controlled Trial. The NutriAge Trial.
Обзор
The goal of this randomised controlled trial is to investigate whether Time-Restricted Eating (TRE) combined with a Low Glycaemic Index Mediterranean Diet can improve cognitive function, metabolic health, and biological ageing in late perimenopausal and menopausal women aged 45-75 years with a BMI ≥23 kg/m². It will consist of a 12-week intervention followed by a 12 week follow-up period. Researchers will compare a group following the 16:8 time-restricted eating schedule and Low Glycaemic Index Mediterranean Diet to a control group (waiting list) receiving no dietary or meal-timing instructions to determine if these dietary strategies influence cognitive function, assessed via brain-derived neurotropic factor (BDNF) and cognitive function tests, metabolic outcomes, biological age, the gut microbiome, tender and swollen joint count and global health. Participants will: Follow a 16:8 time-restricted eating schedule (eating within an 8-hour window and fasting for 16 hours) if assigned to the intervention group. Adhere to a tailored Low Glycaemic Index Mediterranean Diet and track meals using the Nutrium app. Attend study visits at the University of Nicosia at Week 0, Week 12, and Week 24 for various assessments. Provide biological samples, including blood samples at five specific intervals and stool samples at Week 0 and Week 12. Complete multiple questionnaires regarding diet, lifestyle, sleep quality, physical activity, tender and swollen joints, and quality of life. Undergo physical and cognitive assessments, such as CNS Vital Signs tests, blood pressure measurements, and body composition analysis. The two groups will be compared to understand if the intervention improves outcomes and can thus be applied in this population group.
Подробное описание
This randomized controlled trial will run over a period of 24 weeks (6 months) and will be divided into two main phases: a 12-week intervention phase followed by a 12- week follow-up phase designed to assess long-term adherence and health outcomes. The participants will be randomized to one of two groups: the intervention group of a Time-Restricted Eating combined with a Low Glycaemic Index diet (TRE-LGI) group, and the control group which will not receive any dietary intervention.
During the intervention phase (Week 0 to Week 12), participants randomized to the TRE-LGI group will follow a structured eating plan. They will be instructed to consume all their meals within an 8-hour eating window each day and adhere to a low glycaemic index Mediterranean-style diet. Participants randomized to the control group will not receive any dietary intervention but will continue to be monitored for study purposes.
Assessments will be conducted at three time points during this phase. At baseline (Week 0), participants will complete a full set of evaluations, including the online Computerised Neurocognitive Testing tool CNS Vital Signs, metabolic markers (insulin sensitivity, and lipid profiles, C-reactive protein (CRP), BDNF assessment using Enzyme-Linked Immunosorbent Assay (ELISA) Test, biological ageing assessment using the N-glycome analysis (GlycanAge test), gut microbiome analysis from stool samples, body composition, blood pressure, waist circumference, sleep quality using the Pittsburgh Sleep Quality Index (PSQI), physical activity using the International Physical Activity Questionnaire-Short Form IPAQ-SF, tender and swollen joint count and Global Health using the PROMIS® Scale v1.2 - Global Health.
At Week 6, only the N-glycome composition analysis (GlycanAge) will be repeated to monitor changes in biological ageing.
At Week 12, all baseline assessments will be repeated to measure the effects of the intervention.
The follow-up phase, spanning from week 12-24, will focus on evaluating the participants' ability to sustain the dietary practices achieved during the intervention period without receiving further active dietary guidance. Monitoring will continue to measure the longer-term effects on cognitive, metabolic, and biological health outcomes.
At Week 18, participants will undergo N-glycome composition analysis (GlycanAge) to continue monitoring biological ageing.
At Week 24, a final comprehensive assessment will be conducted, including cognitive function (CNS Vital Signs), BDNF Test, N-glycome analysis, body composition using BIA, BMI, blood pressure, waist circumference, and sleep quality (PSQI), physical activity (IPAQ-SF), tender and swollen joint count, and Global Health PROMIS questionnaire.
Participants in the control group will complete the same assessments at each scheduled time point, allowing for direct comparisons; however, they will not undergo any dietary intervention throughout the study.
Вмешательства
- Другое Time-Restricted Low-Glycaemic Index Diet
The combination of a 16:8 Time-Restricted eating period with a low glycaemic index Mediterranean diet
Первичные конечные точки
- Brain-derived neurotrophic factor concentration [Срок оценки: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
Вторичные конечные точки (12)
- Cognitive function [Срок оценки: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Insulin resistance [Срок оценки: Week 0 and Week 12 for the intervention period]
- Lipid profile [Срок оценки: Week 0 and Week 12 for the intervention period]
- C-reactive protein (CRP) [Срок оценки: Week 0 and Week 12 for the intervention period]
- IgG N-glycome composition analysis to assess GlycanAge [Срок оценки: The test will be conducted at Week 0, 6, 12, 18, and 24 to monitor progressive changes in biological ageing throughout the 6-month study period.]
- Anthropometric measurements: Body weight, height, and calculation of the Body Mass Index [Срок оценки: Week 0 and weekly thereafter until Week 24 for body weight and BMI, Week 0: Body height]
- Body composition analysis using Bioelectrical Impedance Analysis [Срок оценки: Week 0 and Week 12 for the intervention phase and Week 24 for the follow-up phase]
- Gut microbiome [Срок оценки: Week 0 and Week 12 for the intervention period]
- Blood pressure [Срок оценки: Week 0 and Week 12 of the intervention period and Week 24 of the follow-up period]
- Sleep duration and quality [Срок оценки: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Tender and swollen joint count [Срок оценки: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
- Global Health [Срок оценки: Week 0 and Week 12 for the intervention period and Week 24 for the follow-up period]
Критерии участия
Критерии включения
- Women in late perimenopausal or menopausal status Note: Late perimenopause is defined as two or more skipped cycles and at least 60 days of amenorrhea. Recent blood tests showing elevated FSH levels support eligibility for late perimenopause. Menopause is defined as 12 consecutive months without a menstrual cycle.
- BMI ≥23 kg/m2
- Age 45-75 years old
- If using any medication, the dose should be stable for the previous 12 months
- Able to use technology and follow the dietary plan
Критерии исключения
- Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD). Note: (Self-reported memory complaints are allowed).
- On hormone replacement therapy (HRT)
- Medical conditions that significantly affect cognitive or metabolic function including diagnosis of type 1 diabetes, severe metabolic disorders, cardiovascular disease, or neurodegenerative conditions, diagnosed eating disorders or severe mental health conditions.
- Currently enrolled in another intervention.
- Severe food allergies or dietary restrictions that would prevent adherence to the study diet.
- History of substance abuse.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Хорватия · 1 центр
- Genos Ltd — Zagreb
Cyprus · 1 центр
- University of Nicosia — Nicosia
Публикации
- Demetriou CA, Hileti D, Onisiphorou E, Kazafanioti C, Alogakos M, Vardakastani D, Christofidou E, Andreou EP, Giannaki CD, Stavrinou PS, Philippou P, Constantinidou F, Philippou E. Associations Between Chrono-Nutrition Behaviours and Cognitive Function in Middle-Aged Adults: The NUTRICO Cross-Sectional Cohort Study. Nutr Bull. 2025 Jun;50(2):262-277. doi: 10.1111/nbu.70000. Epub 2025 Feb 24. PMID 39992029
Идентификаторы
NCT: NCT07378787 · EEBK/EΠ/2025/52